OptiScan OptiScanner 5000
Device Name:
OptiScanner 5000
Manufacturer:
OptiScan Biomedical Corporation, 24590 Clawiter Road, Hayward, CA 94545, UNITED STATES.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The OptiScan OptiScanner 5000 is an automatic blood glucose meter. Although its blood glucose measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
The technology used in the OptiScan OptiScanner 5000, to measure blood glucose, has been assessed, in general and specific populations, according to non-standard protocols.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval None When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.
Validation Publications:

Jax T, Heise T, Nosek L, Gable J, Lim G, Calentine C. Automated near-continuous glucose monitoring measured in plasma using mid-infrared spectroscopy. J Diabetes Sci Technol. 2011 Mar;5(2):345-52. Epub: 2011 Mar 1. doi: 10.1177/193229681100500222. PMID: 21527104. Available from: PMC3125927.

Ad Hoc protocol General population

Barassi A, Umbrello M, Ghilardi F, Damele CA, Massaccesi L, Iapichino G, Melzi d’Eril GV. Evaluation of the performance of a new OptiScanner™ 5000 system for an intermittent glucose monitoring. Clin Chim Acta. 2015 Jan 1;438:252-4. Epub: 2014 Sep 11. doi: 10.1016/j.cca.2014.09.008. PMID: 25218698.

Ad Hoc protocol Critically ill patients

Study suggests that OptiScanner can measure glucose accurately across a wide range of glucose values in plasma of ICU patients

Righy Shinotsuka C, Brasseur A, Fagnoul D, So T, Vincent JL, Preiser JC. Manual versus Automated moNitoring Accuracy of GlucosE II (MANAGE II). Crit Care. 2016;20(1):380. Epub: 2016 Nov 25. doi: 10.1186/s13054-016-1547-3. PMID: 27884157. Available from: PMC5123350.

Ad Hoc protocol Critically ill patients

Mixed results from the application of ISO 15197:2013 and other criteria to samples from 88 ICU patients; however the application of protocol criteria is dependent on the protocol procedure being followed precisely.

Bochicchio GV, Nasraway S, Moore L, Furnary A, Nohra E, Bochicchio K. Results of a multicenter prospective pivotal trial of the first inline continuous glucose monitor in critically ill patients. J Trauma Acute Care Surg. 2017 Jun;82(6):1049-54. doi: 10.1097/TA.0000000000001444. PMID: 28328679.

Ad Hoc protocol Critically ill patients

The authors concluded that the trial demonstrated that the OptiScanner was safe and accurate for use in critically ill surgical and trauma patients.

Relevant Publications:

Umbrello M, Salice V, Spanu P, Formenti P, Barassi A, Melzi d'Eril GV, Iapichino G. Performance assessment of a glucose control protocol in septic patients with an automated intermittent plasma glucose monitoring device. Clin Nutr. 2014 Oct;33(5):867-71. Epub: 2013 Oct 23. doi: 10.1016/j.clnu.2013.10.007. PMID: 24169498.

The publication describes the OptiScan OptiScanner 5000 being used as a reference device for comparison with .

van Hooijdonk RT, Winters T, Fischer JC, van Dongen-Lases EC, Krinsley JS, Preiser JC, Schultz MJ. Accuracy and limitations of continuous glucose monitoring using spectroscopy in critically ill patients. Ann Intensive Care. 2014;4(1):8. Epub: 2014 Mar 6. doi: 10.1186/2110-5820-4-8. PMID: 24598381. Available from: PMC3975731.

The authors concluded that the devices needed calibration for previously unrecognized interferences, after which measurement accuracy of plasma glucose levels improved, but recommended external validation and improvement to the device's automated blood draw system.

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